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U.S. Department of Health and Human Services

Medical Devices

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Letter to IDENTIGENE Concerning the Identigene STD Test

November 4, 2010

Steve Smith, Executive Director
IDENTIGENE
2495 South West Temple
Salt Lake City, UT 84115
Document Number: GEN1001355

Dear Mr. Smith:

It has come to our attention that you are currently marketing the Identigene STD Test, including a home-use urine collection kit, intended for the diagnosis of chlamydia and gonorrhea infection.  The test kit for chlamydia and gonorrhea infection appears to meet the definition of a device asthat term is defined in section 201(h) of the Federal Food Drug and Cosmetic Act.

We have conducted a review of our fies, and have been unable to identify any Food and Drug Administration (FDA) clearance number for the testing device mentioned above.  We request that you provide us with the FDA clearance number for the Identigene STD Test device, including the home-use urine collection kit, used for detecting chlamydia and gonorrhea. If you do not believe that you are required to obtain FDA clearance for the device mentioned above, please provide uswith the basis for that determination.

We have assigned a unique document number that is cited above. The requested information should reference this document number and should be submitted to:

James L. Woods, W066, Office 5688
Deputy Director
Patient Safety and Product Quality
Office of In vitro Diagnostic Device Evaluation and Safety
10903 New Hampshire Avenue
Silver Spring, MD 20993

We would appreciate a response within 15 days from the date of this letter. If you have questions relating to this matter, please feel free to call Sally Hojvat, M.Sc., Ph.D. at 301-796-5455, or log on to our web site at www.fda.gov for general information relating to FDA device requirements.

Sincerely yours,

/S/

James L. Woods
Deputy Director Patient Safety and Product Quality
Office of In vitro Diagnostic Device Evaluation and Safety
Center for Devices and Radiological Health